中华人民**国
PEOPLE’S REPUBLIC OF CHINA
医疗器械产品出口销售证明
CERTIFICATE FOR EXPORTATION OF MEDICAL
PRODUCTS
证书编号:赣吉市监械出****0003号
Certificate NO.:Gan ji Food and Drug Administration NO.****0003
产品名称:一次性使用J型导管,一次性使用输尿管导引鞘,一次性使用非血管腔道导丝,一次性使用输尿管扩张器,一次性使用尿道扩张器
Product(s): Disposable Ureteral Stent,Ureteral Access Sheath,Guide Wire,Ureteral Dilator Set,Urethral Dilator Set
规格型号:见附页
Model: See Attachment
产品注册或备案凭证号:见附页
Registration certificate(s): See Attachment
生产企业:****
Manufacturer:Jiangxi Langhe Medical Instrument Co.,Ltd
生产企业住所:江****工业园南区
Address of manufacturer Residence: South Area, Yongfeng Industrial Zone, Yongfeng County,Ji’an City Jiangxi Province, P.R.China
生产地址:**省吉****工业园区生物产业园北侧
Production address: North Side of the Biological Industrial Park, Enjiang Industrial Zone ,Yongfeng County,Ji’an City, Jiangxi Province, China
生产许可或备案凭证号:赣食药监械生产许****0055号
Manufacturing License(s): Jiangxi SFDA manufacturing permit for medical products Certificate No.****0055
兹证明上述产品已准许在中国生产和销售。
This is to certify that the above products have been registered to be manufactured and sold in China.
证明有效日期至:2023年03月01日
This certification valid until: March 01, 2023
备注:无
Remark:None
****管理局
2021年3月3日
医疗器械产品出口销售证明书附页
ATTACHMENT OF CERTIFICATE FOR
EXPORTATION OF MEDICAL PRODUCTS
证书编号:赣吉市监械出****0003号
Certificate NO.:Gan ji Food and Drug Administration NO.****0003
序号 SN | 产品名称 Products | 规格型号 Model | 注册证号 Registration Certificate |
1 | 一次性使用J型导管 Disposable Ureteral Stent | 型号: 双J型:3Fr,4Fr,4.5Fr,4.8Fr,5Fr,6Fr, 7Fr,8Fr 单J型:3Fr,4Fr,4.5Fr,4.8Fr,5Fr,6Fr, 7Fr,8Fr,9Fr,10Fr,12Fr,14Fr,16Fr 多圈型:5Fr,6Fr,7Fr,8Fr
Model: Doubel J Ureteral Stent:3Fr,4Fr, 4.5Fr,4.8Fr,5Fr,6Fr,7Fr,8Fr Single J Ureteral Stent:3Fr,4Fr, 4.5Fr,4.8Fr,5Fr,6Fr,7Fr,8Fr,9Fr,10Fr,12Fr,14Fr,16Fr Multi-Length Ureteral Stent:5Fr,6Fr,7Fr,8Fr | 赣械注准201****0198
Gan ji Food and Drug Administration NO.201****0198 |
2 | 一次性使用输尿管导引鞘 Ureteral Access Sheath | 型号:UAS-1013,UAS-1020,UAS-1028,UAS-1035,UAS-1045,UAS-1055,UAS-1213,UAS-1220,UAS-1228,UAS-1235,UAS-1245,UAS-1255,UAS-1413,UAS-1420,UAS-1428,UAS-1435,UAS-1445,UAS-1455 Model: UAS-1013,UAS-1020,UAS-1028,UAS-1035,UAS-1045,UAS-1055,UAS-1213,UAS-1220,UAS-1228,UAS-1235,UAS-1245,UAS-1255,UAS-1413,UAS-1420,UAS-1428,UAS-1435,UAS-1445,UAS-1455 | 赣械注准202****0025
Gan ji Food and Drug Administration NO.202****0025
|
3 | 一次性使用非血管腔道导丝 Urological Guide Wire | 型号:TC-028080、TC-032080、TC-035080、TC-038080、TC-028150、TC-032150、TC-035150、TC-038150、QS-025080、QS-035080、QS-025150、QS-032150、QS-035150、QS-038150、QS-025080W、QS-035080W、QS-025150W、QS-032150W、QS-035150W、QS-038150W、QS-025150Y、QS-035080Y、QS-035150Y、QS-038150Y、QS-025150WY、QS-035080WY、QS-035150WY、QS-038150WY、BM-025150、BM-028150、BM-032150、BM-035150、BM-038150、BM-025150W、BM-028150W、BM-032150W、BM-035150W、BM-038150W Model: TC-028080、TC-032080、TC-035080、TC-038080、TC-028150、TC-032150、TC-035150、TC-038150、QS-025080、QS-035080、QS-025150、QS-032150、QS-035150、QS-038150、QS-025080W、QS-035080W、QS-025150W、QS-032150W、QS-035150W、QS-038150W、QS-025150Y、QS-035080Y、QS-035150Y、QS-038150Y、QS-025150WY、QS-035080WY、QS-035150WY、QS-038150WY、BM-025150、BM-028150、BM-032150、BM-035150、BM-038150、BM-025150W、BM-028150W、BM-032150W、BM-035150W、BM-038150W | 赣械注准201****0039
Gan ji Food and Drug Administration NO.201****0039 |
4 | 一次性使用输尿管扩张器 Ureteral Dilator Set | 型号:单只装、套装; Model:Single, Set | 赣械注准202****0026
Gan ji Food and Drug Administration NO.202****0026 |
5 | 一次性使用尿道扩张器Urethral Dilator Set | 型号:S型、直线型; 规格:单只装、套装; Model:S Curve, Standard Type:Single, Set | 赣械注准201****0150
Gan ji Food and Drug Administration NO.201****0150 |